Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation

NCT06012006 | Not Yet Recruiting

• 1 other identifier: APHP221339
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to determine the individual threshold of minimal clinical change (MCID) for each component of the Multidimensional Dyspnea Profile (MDP) questionnaire in COPD patients undergoing pulmonary rehabilitation.

Conditions

COPD

Keywords

Breathlessness; MCID; COPD; MDP; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (3)

• multidimensional (MDP) questionnaire

  The multidimensional questionnaire measuring the sensory component of dyspnea (intensity of the 5 respiratory descriptors) and the affective component of dyspnea (immediate discomfort and intensity of emotional responses). The MDP will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

• sensory Borg scale

  The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

• affective Borg scale

  The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

Secondary Outcomes (10)

• Affective and Sensory dyspnea visual analog scale (VAS)

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

• mMRC (Modified Medical Research Council) dyspnea score

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

• Dyspnoea 12

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

• COPD Assessment Test (CAT) score

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

• Hospital Anxiety and Depression scale (HADS)

  at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

Study Arms (1)

pulmonary rehabilitation

EXPERIMENTAL

COPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center.

Other: constant work-rate cycling exercise test

Interventions

constant work-rate cycling exercise test OTHER

Description: at the end of pulmonary rehabilitation, a constant work-rate second cycling exercise test will be performed with the same duration as the cycling exercise test at inclusion

pulmonary rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gold B or D COPD patient
• Moderate to severe obstructive ventilatory disorder (FEV1\<80%)
• Admitted for a pulmonary rehabilitation
• Having given free, informed and written consent

You may not qualify if:

• Lack of French language skills, preventing completion of questionnaires
• Cognitive impairment preventing completion of questionnaires
• Patient under guardianship
• Patient not affiliated to the social security system
• Chronic ethylism

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Capucine Morelot-Panzini, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Capucine Morelot-Panzini, MD-PhD

CONTACT

0142167771; capucine.morelot@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 25, 2023
• Study Start: September 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal